Consulting Wallah › Device Explorer › Orthopaedic implants › Knee femur stem prosthesis
Device Explorer · FDA GUDID · GMDN 48066

Knee femur stem prosthesis

A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-

US‑registered devices2,938in commercial distribution
Companies26labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Waldemar Link Gmbh & Co. Kg47416%
Biomet Orthopedics, Llc46516%
Zimmer, Inc.30610%
Exactech, Inc.2609%
Corentec Co., Ltd2167%
Depuy (Ireland)1796%
Microport Orthopedics Inc.1646%
Smith & Nephew, Inc.1415%

Top labelers

CompanyDevicesShare
Waldemar Link Gmbh & Co. Kg47416%
Biomet Orthopedics, Llc46516%
Zimmer, Inc.30610%
Exactech, Inc.2609%
Corentec Co., Ltd2167%
Depuy (Ireland)1796%
Microport Orthopedics Inc.1646%
Smith & Nephew, Inc.1415%
Howmedica Osteonics Corp.1324%
Omni Life Science, Inc.1164%
Ortho Development Corporation1134%
Medacta International Sa592%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GMRSDuraconMRSKinemaxTriathlonHLS Noetos RevisionHLS NoetosUnity Total Knee SystemRotaglide+ Modular Knee System with Fixed MeniscU2 Total Knee SystemMegasystem CEndo-Model Modular Knee Prosthesis SystemEndo-Model SL Knee Prosthesis SystemModular Stem,LINK Endo-Model EVO Knee SystemLINK Endo-Model EVO

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM1,698
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem777
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL665
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN432
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 406
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M274

GMDN & GCC registration

  • GMDN code 48066 · implantable
  • Single‑use 99% · sterile 99% · Rx‑only 98% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 762Outer Diameter (Millimeter) · 446Width (Millimeter) · 32Length (Inch) · 27Angle (degree) · 10Height (Millimeter) · 9

Use these as the dimensions to specify in a tender line.

How many knee femur stem prosthesis products are registered in the US?

2,938 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee femur stem prosthesis", from 26 companies. The largest labeler is Waldemar Link Gmbh & Co. Kg with 16% of records.

Which FDA product codes apply?

JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), KRO (PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL), MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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